MyopiaNCT02854891
Ambient Light Levels in the Kindergarten and Schools and the Relation to Refractive Development
An observational study of Myopia, run by Hillel Yaffe Medical Center.
Trial summary
Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained elongation of the eye globe There are number of theories concerning the environmental effect on the emmetropization process, most are related to childhood exposure to outdoor activity, near work and sleep with night light. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- autorefractometer, A-scan ultrasound
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Two hundred children at ages range from kindergarten to junior year of high-school (4-17), enrolled in the formal education system in hadera and it surrounding.
Who may be able to join
- Every child that have been studying in the same class for the last 6-12 months (kindergarten and school respectively).
Who cannot join
- Noncooperative child or parents.
- Ocular surgery.
- Ocular genetic disease.
About this study
Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained elongation of the eye globe There are number of theories concerning the environmental effect on the emmetropization process, most are related to childhood exposure to outdoor activity, near work and sleep with night light. Studies in lab animals found an association between intensity of ambient lighting and myopia development.
In this study, the investigators will examine the ambient light in kindergarten and schools and their relation to refractive error. Diurnal luminance in kindergarten and school class room will be measured and correlated to biometric measures such as refraction, axial length and keratometry.
- Conditions
- Myopia
- Being tested
- autorefractometer, A-scan ultrasound
- Keywords
- Effects, Heat, Light
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autorefractometer, A-scan ultrasoundOther
A measurement of refraction will be made by the Autorefractometer. A measurement of the eyes' biometer data will be made by A-scan ultrasound.
What is being measured
The primary outcome is the main question the study is designed to answer.
the relation between the level of myopia and light intensity
an analysis of the correlation between the two variables. the data will be collected as reported in the secondary outcome measures (number 2 and 5).
Measured: change from baseline at the start point of the study, after 6 months and after 12 months
Secondary outcomes (5)
levels of ambient light intensity
Classes that are influenced by sunlight will be examined for light levels at a specific day of each month . For classes that are not influenced by sunlight, light source and levels will be documented. the measurement will be held until study completion.
will be measured by luxmeter. the results will be in LUX (standardised unit of measurement of light intensity)
Measured: natural light- start of study and once a month until completion, average of 1 year. artificial light- once at the start point of the study
measurement of axial length
will be measured using A-scan ultrasound. the results will be in millimeters.
Measured: change from baseline at the start point of the study, after 6 months and after 12 months
measurement of Visual acuity
will be measured using LogMAR chart.
Measured: change from baseline at the start point of the study, after 6 months and after 12 months.
measurement of refraction
will be measured using autorefractometer. the results will be in diopter
Measured: change from baseline at the start point of the study, after 6 months and after 12 months.
measurement of cornea curvature
will be measured using autorefractometer. the results will be in millimeters.
Measured: change from baseline at the start point of the study, after 6 months and after 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854891
- Sponsor's protocol ID
- 0027:16
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambient Light Levels in the Kindergarten and Schools and the Relation to Refractive Development
- ClinicalTrials.gov ID
- NCT02854891
- Acronym / sponsor ID
- 0027:16
- Conditions
- Myopia
- Keywords
- Effects, Heat, Light
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained elongation of the eye globe There are number of theories concerning the environmental effect on the emmetropization process, most are related to childhood exposure to outdoor activity, near work and sleep with night light. Studies in lab animals found an association between intensity of ambient lighting and myopia development.
In this study, the investigators will examine the ambient light in kindergarten and schools and their relation to refractive error. Diurnal luminance in kindergarten and school class room will be measured and correlated to biometric measures such as refraction, axial length and keratometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Two hundred children at ages range from kindergarten to junior year of high-school (4-17), enrolled in the formal education system in hadera and it surrounding.
Key inclusion criteria (1 listed)
- Every child that have been studying in the same class for the last 6-12 months (kindergarten and school respectively).
Key exclusion criteria (3 listed)
- Noncooperative child or parents.
- Ocular surgery.
- Ocular genetic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autorefractometer, A-scan ultrasoundA measurement of refraction will be made by the Autorefractometer. A measurement of the eyes' biometer data will be made by A-scan ultrasound. | Other | – |
Primary outcome
the relation between the level of myopia and light intensity
Time frame: change from baseline at the start point of the study, after 6 months and after 12 months
an analysis of the correlation between the two variables. the data will be collected as reported in the secondary outcome measures (number 2 and 5).
5 secondary outcomes
levels of ambient light intensity
Time frame: natural light- start of study and once a month until completion, average of 1 year. artificial light- once at the start point of the study
measurement of axial length
Time frame: change from baseline at the start point of the study, after 6 months and after 12 months
measurement of Visual acuity
Time frame: change from baseline at the start point of the study, after 6 months and after 12 months.
measurement of refraction
Time frame: change from baseline at the start point of the study, after 6 months and after 12 months.
measurement of cornea curvature
Time frame: change from baseline at the start point of the study, after 6 months and after 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relation between the level of myopia and light intensity (time frame: change from baseline at the start point of the study, after 6 months and after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.